Moderators: Mr J. Reynier, France, and Ms M. Tala fallow, The Gambia

Drug regulation is an essential public health function to combat the current global and local challenges concerning poor quality and circulation of ineffective and harmful drugs. Worldwide, only one out of six countries has established fully-developed drug regulatory capacity. Moreover, two out of six countries have very limited drug regulation in place.

Harmonization efforts are essential to promote safe trade in starting materials, intermediates, and finished products, thereby assuring that safe products reach patients.

WHO strategies to meet these challenges include efforts to:

• provide global guidance in the areas of quality, safety and efficacy, drug information, and harmonization.

• strengthen national drug regulation through information exchange and networking, provision of guidelines, manuals and training programmes, and direct support to countries.